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JUNE 2019 page 51

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. See captodayonline.com/productguides for an interactive version of guide.

CHEMISTRY and IMMUNOASSAY ANALYZERS

for POINT–OF–CARE and LOW–VOLUME LABORATORIES

JUNE 2019 | CAP TODAY 51


Part 1 of 6 Abbott Point of Care Awareness Technology Beckman CoulterSudip Ghatak [email protected] Riki Russell [email protected] Alan Cotton [email protected], NJ Palm City, FL Brea, CA609-454-9000 www.pointofcare.abbott/us/en/home 772-283-6540 www.awaretech.com 800-526-3821 www.beckmancoulter.com

Name of instrument i-STAT 1 analyzer ChemWell 2910 Access 2Type of instrument combination chemistry/immunoassay combination chemistry/immunoassay immunoassay

Operational type/Model type discrete/handheld batch, random access/benchtop continuous random access/benchtopList price/First year sold in U.S. —/2000 $32,000/1998 —/2001Targeted hospital bed size/Targeted test volume all/— 200–500/200–400 —Company manufactures instrument yes (also sold by McKesson, Henry Schein, Medline) yes (also sold by GMI, Monobind, ASI, others) yes (also sold by McKesson, Henry Schein)Other models in this family of analyzers — ChemWell Fusion, ChemWell-T, ChemWell 2902 Unicel DxI 600, Unicel DxI 800No. of units in clinical use in U.S./Outside U.S. (countries) > 30,000/> 10,000 (Europe, Latin America, Africa, Middle

East, Asia Pacific)11/2,393 (India, UK, Germany, Dubai, China, Iran, Korea) > 2,000/> 9,000

Dimensions (H × W × D)/Instrument footprint 9.25 × 3 × 2.85 in./< 1 sq. ft. 18.63 × 36.25 × 21.5 in./6 sq. ft. 19.5 × 39 × 24 in./additional clearance of 2 in. on sides and rear, 24 in. on top

Weight empty/Weight fully loaded < 2 lbs./< 2 lbs. 78 lbs./78 lbs. 200 lbs./—No. of different measured assays onboard simultaneously — 15 (12 can be run and calibrated at one time) 24 (24 can be run and calibrated at one time)No. of user-definable (open chemistry) channels — — 0Test throughput per hour/Assay run time —/2–10 min. 200 (27 tests in throughput)/6–120 min. up to 100/13–55 min.

Chemistry:No. of direct ion-selective electrode channels up to 26 — —Detection methods potentiometry, amperometry, conductometry photometry —Stat time until completion/specimen throughput for:• Ion-selective electrode 2 min./20–25 — —• Basic metabolic panel 2 min./20–25 — —• Complete metabolic panel — — —Typical time delay from ordering stat test until aspiration of sample none — —

Immunoassay:Fully automated microplate immunoassay system yes (up to 26 tests per unit) yes (27–44 tests per unit; 96 wells per microplate) noMethodologies supported potentiometry, amperometry, conductometry enzyme immunoassay, colorimetric analysis chemiluminescenceSeparation methodologies none necessary coated microwell magnetic particleStat time until completion of a ß-hCG test 10 min. — 15 min.• Typical time delay from test order to aspiration of sample none — 36 sec.Stat time until completion of a cTn test 10 min. — 17 min.• Typical time delay from test order to aspiration of sample none — 36 sec.

Approximate No. of tests per reagent set/Reagent type —/self-contained single use —/open reagent system 50 per pack or 100 per kit/self-contained multiuseReagents refrigerated onboard/Reagents ready to use no/— yes (12°–15°C via optional reagent cooling accessory;

otherwise room temperature)/yesyes (2–8°C)/yes

Reagent lot tracking/Reagent inventory no/no yes/yes yes/yesReagent form/Reagents barcoded dry chemistry, liquid chemistry (closed reagent system)/yes liquid chemistry (open reagent system)/no liquid chemistry (closed reagent system)/yesSeparate reagent pack for each specimen/for each test run no/no no/yes no/noWalkaway capability/Walkaway duration yes/2–10 min. or 1 specimen or up to 13 tests yes/— yes/180 min. or 60 specimens

Design of sample-handling system — rack rackUses washable cuvettes/Uses disposable cuvettes no/no no/no no/yes (can store up to 294 cuvettes)Min.–max. sample volume that can be aspirated at one time 17–95 µL 2–250 µL 5–200 µLMin. reaction volume/Min. specimen volume/Min. dead volume — 100 µL/100 µL/100 µL —/—/100 µLDedicated pediatric sample cup no no yes (dead volume: 100 µL)Primary tube sampling no yes yesAccommodates most standard tube sizes/Accepts nonstandard tube sizes

no/no yes/yes (13 mm) yes/no

Pierces caps on primary tubes no no noProtects against probe collision no yes noDetects clots/liquid level/short sample yes/yes/yes no/yes/yes yes/yes/yesDetection or quantitation for hemolysis, icterus, lipemia, clots detection for hemolysis, icterus, lipemia, clots — detection for clots; hemolysis, icterus, lipemia not availableDilutes patient samples onboard/Susceptibility to carryover no/— yes (can be programmed to perform dilutions prior to analysis)/— yes (can be programmed to perform dilutions prior to analysis)/—Automatic rerun capability no yes noSample volume can be diluted to rerun out-of-linear-range high results no yes yesSample volume can be concentrated to rerun out-of-linear-range low results

no yes no

Analyzer requires dedicated water supply no no noAutocalibration/Multipoint calibration supported yes (calibrants are not stored onboard)/yes (recommended

avg. frequency: each test)no (calibrants can be stored onboard)/yes (recommended avg. frequency: test dependent)

no (calibrants are not stored onboard)/yes (recommended avg. frequency: 28 days)

Typical calibration frequency for ISE/therapeutic drugs/ drugs of abuse/general chemistries/immunoassays

—/—/—/each test/each test — —/—/—/—/28 days

Automatic programmable start/Automatic programmable shutdown yes/yes no/no no (< 5 min. start-up time)/noOnboard real-time QC/Onboard software capability to review QC yes/yes yes/yes no/yesSupports multiple QC lot numbers per analyte yes yes yesWaste management manually by user manually by user, automated collection onboard instrument,

direct to drainautomated collection onboard instrument

Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, EAN 8, EAN 13)/—

yes (Code 39)/no yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/no

Lab can control analyzer from remote computer yes yes yesInstrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)System malfunctions can be diagnosed via remote monitoring yes yes yesUPS backup power supply no no noData-management capability/LIS or EHR systems interfaced optional add-on/— onboard/— onboard/Cerner, Antrim, CCA, Chemware, Dawning Technologies,

ADAC, Dynamic Healthcare, Antek, Siemens, McKesson, moreLIS interface provided/Bidirectional interface capability yes (additional cost)/no no/no yes (included in instrument price)/yes (host query)Modem servicing provided/Service engineer on-site response time —/— (product replacement within 24 hrs.) no/— yes/< 24 hrs.

Mean time between failures — (displays error codes for troubleshooting) — (displays error codes for troubleshooting) avg. 1.2 service calls per year (displays error codes for troubleshooting)

Average scheduled maintenance time by lab personnel — daily: 8 hrs. daily: 5 min./operator; 27 min./system; weekly: 15 min./operator; 68 min./system

Maintenance records kept onboard for user/vendor — no/no no/noMaintenance training demonstration module onboard — no yesTraining included with purchase/Avg. time for basic user training —/4 hrs. (at customer site) yes (1 training slot)/4 days (at vendor site) yes (2 training slots)/2 days (at vendor site)Advanced operator training/Extra charge for follow-up or advanced training

yes (at customer site)/no yes (at vendor site)/yes (depends on custom requirements) yes (at vendor site)/—

Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (1 year)/$6,000 yes (1 year)/—

Distinguishing features (supplied by company)

Note: a dash in lieu of an answer means company did not answer question or question is not applicable

• handheld portable analyzer; unit use system can perform chemistry, blood gas, cardiac marker, and coagulation tests

• CLIA-waived menu of tests, including basic metabolic panel• uses 2–3 drops of whole blood or plasma

• vertical plate reading for biochemistries• reagent savings• 2-in-1 utility with the ability to run in either ELISA mode or

biochemistry mode

• standardization of results and reagents across all volume segments

• reliable benchtop system providing the same high-quality results as the core lab


JUNE 2019 page 52


52 CAP TODAY | JUNE 2019 CHEMISTRY and IMMUNOASSAY ANALYZERS

Part 2 of 6 Beckman Coulter Diatron MI Dynex TechnologiesJeffrey Owen [email protected] Frank Matuszak [email protected] German Nunez [email protected], CA Medley, FL Chantilly, VA714-961-4966 www.beckmancoulter.com 833-228-7931 www.diatron.com 703-803-1457 www.dynex.com

Name of instrument AU480 Pictus 500 (P500) DS2 Automated ELISA SystemType of instrument chemistry chemistry immunoassay

Operational type/Model type continuous random access/floor standing batch, random access, continuous random access, discrete/benchtop

batch/benchtop

List price/First year sold in U.S. —/2009 $42,860/2016 $57,607/2007Targeted hospital bed size/Targeted test volume —/daily: 400 tests/800 ISE 20–100/daily: 500–2,500; monthly: 15,000–75,000; annual:

182,500–912,500—/daily: < 4 microplates (96-well microplates)

Company manufactures instrument yes (also sold by McKesson, Henry Schein, Medline) yes yes (also sold by Fisher Scientific, Zeus Scientific, others)Other models in this family of analyzers DxC 700 AU, AU5800 Pictus 700 (P700) DSXNo. of units in clinical use in U.S./Outside U.S. (countries) — > 40/≤ 200 (Europe, Latin America, Africa, Middle East, Asia) 700/3,400 (Belgium, Czech Republic, Egypt, Germany, others)Dimensions (H × W × D)/Instrument footprint 47.5 × 57 × 30 in./18.5 sq. ft. 24.4 × 35.4 × 26 in./6.4 sq. ft. 26 × 21 × 27 in./3.7 sq. ft.Weight empty/Weight fully loaded — 253 lbs./271 lbs. 105 lbs./—No. of different measured assays onboard simultaneously 63 (63 can be run and calibrated at one time) 72 (999 can be run and calibrated at one time) up to 12 assays per microplate (up to 12 can be run)No. of user-definable (open chemistry) channels 18 (76 can be active simultaneously) — — (open system; up to 12 can be active simultaneously)Test throughput per hour/Assay run time 800 (400 photometric, 800 with ISE)/8.5 min. 500/30–1,200 sec. (avg. 300 sec.) assay dependent (up to 384 tests per run)/assay dependent

Chemistry:No. of direct ion-selective electrode channels 3 3 —Detection methods photometry, potentiometry photometry, potentiometry —Stat time until completion/specimen throughput for:• Ion-selective electrode 4.5 min./400 specimens per hr. 2 min./60 specimens per hr. —• Basic metabolic panel 12.5 min./133 specimens per hr. 7.5 min./45 specimens per hr. —• Complete metabolic panel 14.5 min./72 specimens per hr. 9 min./25 specimens per hr. —Typical time delay from ordering stat test until aspiration of sample 60 sec. 24 sec. —

Immunoassay:Fully automated microplate immunoassay system — — yes (up to 12 tests per unit; 96 wells per microplate)Methodologies supported — — enzyme immunoassaySeparation methodologies — — coated microwellStat time until completion of a ß-hCG test — — —• Typical time delay from test order to aspiration of sample — — —Stat time until completion of a cTn test — — —• Typical time delay from test order to aspiration of sample — — —

Approximate No. of tests per reagent set/Reagent type 200 per kit/self-contained multiuse 50–200 per set, 400–1,800 per pack/self-contained multiuse, open reagent system

—/open reagent system

Reagents refrigerated onboard/Reagents ready to use yes (4°–12°C)/yes yes (8°±2°C)/yes no (23°±4°C)/—Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yesReagent form/Reagents barcoded liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/no liquid chemistry (open reagent system)/yesSeparate reagent pack for each specimen/for each test run no/no no/no no/yesWalkaway capability/Walkaway duration yes/— yes/180 min. or 95 specimens or 1,200 tests/assays yes/up to 192 specimens or up to 192 tests/assays

Design of sample-handling system rack rack rackUses washable cuvettes/Uses disposable cuvettes yes/no yes/yes (can store up to 80 cuvettes) no/—Min.–max. sample volume that can be aspirated at one time 1–25 µL 2–100 µL 10–300 µLMin. reaction volume/Min. specimen volume/Min. dead volume 90 µL/41 µL or 1 uL with 4 mm above gel barrier/50 µL 180 µL/22 µL/100 µL 10 µL/—/—Dedicated pediatric sample cup yes (dead volume: 50 µL) yes (dead volume: 20 µL) noPrimary tube sampling yes yes yesAccommodates most standard tube sizes/Accepts nonstandard tube sizes

yes/yes (primary, secondary tubes: 11.5–16 mm diameter, 55–102 mm height; nested micro cups)

yes/no yes/yes (17 × 100 mm)

Pierces caps on primary tubes no yes noProtects against probe collision no yes noDetects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/yesDetection or quantitation for hemolysis, icterus, lipemia, clots detection and quantitation for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available detection for clots; hemolysis, icterus, lipemia not availableDilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform sample dilutions prior to

analysis)/0.001 parts per millionyes (can be programmed to perform dilutions prior to analysis)/30 parts per million

yes (can be programmed to perform dilutions prior to analysis)/0 parts per million

Automatic rerun capability yes yes noSample volume can be diluted to rerun out-of-linear-range high results yes yes yesSample volume can be concentrated to rerun out-of-linear-range low results

yes yes no

Analyzer requires dedicated water supply yes (20 L/hr. consumption during operation) no (2 L/hr. consumption during operation) noAutocalibration/Multipoint calibration supported yes (calibrants are not stored onboard)/yes (recommended

avg. frequency: assay dependent) yes (calibrants can be stored onboard)/yes (recommended avg. frequency: 7 days)

no (calibrants are not stored onboard)/yes (recommended avg. frequency: assay dependent)


1 day/14 days/14–20 days/30 days/— 8 hrs./—/7 days/14 days/14 days —/assay dependent/assay dependent/—/assay dependent

Automatic programmable start/Automatic programmable shutdown yes (90 sec. start-up time)/yes no/no no/noOnboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yesSupports multiple QC lot numbers per analyte yes yes yesWaste management direct to drain manually by user, direct to drain automated collection onboard instrument

Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/no yes (UPC, Codabar, Code 39, Code 128, Code 93)/yesLab can control analyzer from remote computer yes yes noInstrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)System malfunctions can be diagnosed via remote monitoring yes yes yesUPS backup power supply yes yes yesData-management capability/LIS or EHR systems interfaced onboard/Cerner, Antrim, CCA, Chemware, Dawning Technologies,

ADAC, Dynamic Healthcare, Antek, Siemens, McKesson, moreonboard/AP Vision, Medicus, Schuyler, Labtrack, Labdag, Medytox

onboard/Orchard, Cerner

LIS interface provided/Bidirectional interface capability yes (included in instrument price)/yes (broadcast download and host query)

yes (additional cost)/yes (broadcast download and host query) no/yes (host query)

Modem servicing provided/Service engineer on-site response time yes/< 24 hrs. no/48 hrs. no/24 hrs.

Mean time between failures avg. 2 per year (displays error codes for troubleshooting) 1 per year (displays error codes for troubleshooting) 250 days (displays error codes for troubleshooting)Average scheduled maintenance time by lab personnel daily: 6 min./operator; 4–7 min./system; weekly: 10 min./

operator; 62 min./system; monthly: 45 min./operator; 4 min./system

daily: 30 min.; weekly: 1 hr.; monthly: 2 hrs. daily: 10 min.; weekly: 5 min.

Maintenance records kept onboard for user/vendor yes/no no/no no/noMaintenance training demonstration module onboard yes no noTraining included with purchase/Avg. time for basic user training yes (2 training slots)/3 days (at customer and vendor sites) yes (2 training slots)/3 days (at customer site) no/3 days (at customer site)Advanced operator training/Extra charge for follow-up or advanced training

yes (at vendor site)/yes ($2,500) yes (at vendor or customer site)/yes yes (at customer site)/yes

Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (1 year)/ $5,500 yes (1 year)/—



• standardization across the AU family of chemistry analyzers from low end to ultra high volume

• lower total cost of ownership due to fewer consumables and concentrated reagents

• most common parts can be changed in 3 steps in less than 60 seconds and without tools

• uninterrupted workflow• Windows-based, intuitive, user-friendly software• high-quality components for long stability and result

reliability

• run any assay from any vendor—fully automated open system• reliable workload scheduling—more than 98 percent mean

time between failures• saves space—less than 4 sq. ft. of linear counter space to

process up to two 96-well microplates and 100 specimens


JUNE 2019 page 54



Part 3 of 6 ELITechGroup ELITechGroup Gold Standard DiagnosticsDianna Poissant [email protected] Dianna Poissant [email protected] Christina Brusca [email protected], RI Smithfield, RI Davis, CA401-642-8400 www.elitechgroup.com 401-642-8400 www.elitechgroup.com 530-759-8000 www.gsdx.us

Name of instrument Envoy 500/Envoy 500+ Selectra ProM BoltType of instrument chemistry chemistry immunoassay

Operational type/Model type batch, random access, continuous random access, discrete/benchtop

batch, random access, continuous random access, discrete/benchtop

batch/benchtop

List price/First year sold in U.S. $85,000/2005 (Envoy 500), 2014 (Envoy 500+) $64,375/2012 —/2016Targeted hospital bed size/Targeted test volume —/daily: 20–80 patients; monthly: 4,200–17,000; annual:

50,000–200,000—/daily: 10–40 patients; monthly: 3,333–8,333; annual: 40,000–100,000

—

Company manufactures instrument — (also sold by McKesson, Henry Schein, Medline) yes (also sold by McKesson, Henry Schein, Medline) yes (also sold by distribution partners)Other models in this family of analyzers — Selectra ProS —No. of units in clinical use in U.S./Outside U.S. (countries) 250/— 25/6,000 —

Dimensions (H × W × D)/Instrument footprint 27 × 40 × 23 in./10 sq. ft. 30 × 48 × 24.4 in./8.1 sq. ft. 22 × 19 × 21 in./8 sq. ft.Weight empty/Weight fully loaded 209 lbs./219 lbs. 210 lbs./— 60 lbs./110 lbs.No. of different measured assays onboard simultaneously 40 (40 can be run and calibrated at one time) 36 (96 can be run and calibrated at one time) open EIA platform (up to 12 with limit of two washes, nine

reagents and common incubation temperature, plate frame type)No. of user-definable (open chemistry) channels 500 (40 can be active simultaneously) 10 (10 can be active simultaneously) —Test throughput per hour/Assay run time 490/— 180/— assay dependent (96 tests in throughput)/20 min.–4 hr. (avg. 2 hr.)

Chemistry:No. of direct ion-selective electrode channels 4 4 —Detection methods potentiometry potentiometry —Stat time until completion/specimen throughput for:• Ion-selective electrode 3 min., 45 sec./37 specimens per hr. 5 min./66 specimens per hr. —• Basic metabolic panel 10 min./588 specimens per hr. —/27 specimens per hr. —• Complete metabolic panel 15 min./266 specimens per hr. 13 min., 35 sec./12 specimens per hr. —Typical time delay from ordering stat test until aspiration of sample < 1 min. 3 min. —

Immunoassay:Fully automated microplate immunoassay system — — yes (96 tests per unit; 96 wells per microplate)Methodologies supported — — chemiluminescence, enzyme immunoassaySeparation methodologies — — coated microwellStat time until completion of a ß-hCG test — — —• Typical time delay from test order to aspiration of sample — — —Stat time until completion of a cTn test — — —• Typical time delay from test order to aspiration of sample — — —

Approximate No. of tests per reagent set/Reagent type varies/open reagent system varies/self-contained multiuse 96/open reagent systemReagents refrigerated onboard/Reagents ready to use yes (10°–15°C)/yes yes (10°C)/yes no (room temperature–40°C)/variable; reagent specificReagent lot tracking/Reagent inventory yes/yes yes/yes yes/noReagent form/Reagents barcoded liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/noSeparate reagent pack for each specimen/for each test run no/no no/no no/yesWalkaway capability/Walkaway duration yes/240 min. or 52 specimens or > 1,000 tests/assays yes/240 min. or 62 specimens or 720 tests/assays yes/avg. 120 min.

Design of sample-handling system ring ring rackUses washable cuvettes/Uses disposable cuvettes yes/no (can store up to 34 cuvettes) yes/no (can store up to 48 cuvettes) no/noMin.–max. sample volume that can be aspirated at one time 1–100 µL 1–30 µL 1–300 µLMin. reaction volume/Min. specimen volume/Min. dead volume 300 µL/1 µL/100 µL 220 µL/1 µL/250 µL 25 µL/151 µL/150 µLDedicated pediatric sample cup no yes (dead volume: 100 µL) noPrimary tube sampling yes yes yesAccommodates most standard tube sizes/Accepts nonstandard tube sizes

yes/yes yes/no yes/no

Pierces caps on primary tubes no no noProtects against probe collision yes yes yesDetects clots/liquid level/short sample yes/yes/yes no/yes/yes no/yes/yesDetection or quantitation for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available hemolysis, icterus, lipemia, clots not available hemolysis, icterus, lipemia, clots not availableDilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to

analysis)/—yes (can be programmed to perform dilutions prior to analysis)/—

yes (can be programmed to perform dilutions prior to analysis)/assay specific

Automatic rerun capability yes yes noSample volume can be diluted to rerun out-of-linear-range high results yes yes noSample volume can be concentrated to rerun out-of-linear-range low results

no no no

Analyzer requires dedicated water supply no (1 L/hr. consumption during operation) no noAutocalibration/Multipoint calibration supported no (calibrants are not stored onboard)/yes no (calibrants are not stored onboard)/yes (recommended

avg. frequency: 28 days)no (calibrants are not stored onboard)/yes (recommended avg. frequency: per batch)


4 hrs./—/—/7–31 days/— 4–8 hrs./2 weeks min./when indicated (if QC fails)/ 28 days/—

—/—/—/—/per batch

Automatic programmable start/Automatic programmable shutdown yes (7 min. start-up time)/no yes (15 min. start-up time)/yes no (5 min. start-up time)/noOnboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yesSupports multiple QC lot numbers per analyte yes yes yesWaste management automated collection onboard instrument, direct to drain automated collection onboard instrument, direct to drain manually by user

Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/no yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes yes (unspecified)/noLab can control analyzer from remote computer no no noInstrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)System malfunctions can be diagnosed via remote monitoring yes yes yesUPS backup power supply yes yes noData-management capability/LIS or EHR systems interfaced onboard/CGM LabDaq, Schuyler House SchuyLab,

McKesson Horizon Lab, Medicus Solutionsonboard/ CGM LabDaq, Schuyler House SchuyLab, McKesson Horizon Lab, Medicus Solutions

onboard/—

LIS interface provided/Bidirectional interface capability no/yes (host query) no/yes (broadcast download and host query) no/yes (host query) Modem servicing provided/Service engineer on-site response time no/24 business hrs. yes/24 business hrs. yes/48 hrs.

Mean time between failures — (displays error codes for troubleshooting) — (displays error codes for troubleshooting) — (displays error codes for troubleshooting)Average scheduled maintenance time by lab personnel weekly: 15 min.; monthly: 15 min. daily: 5 min.; weekly: 5 min.; monthly: 15 min. daily: 5 min.; weekly: 15 min.; monthly: 20 min.Maintenance records kept onboard for user/vendor yes/no yes/no yes/some records (dye tests and calibrations)Maintenance training demonstration module onboard no no noTraining included with purchase/Avg. time for basic user training yes (2 training slots)/3 days (at customer site) yes (2 training slots)/3 days (at customer site) yes (No. of training slots client dependent)/4 hrs. (at customer

or vendor site)Advanced operator training/Extra charge for follow-up or advanced training

yes (at customer site)/no yes (at customer site)/no yes (customer or vendor site)/yes (client dependent)

Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/$8,995 (M–F, 8 am–8 pm) yes (1 year)/$4,500 (M–F, 8 am–8 pm) yes (1 year)/—



• fast benchtop chemistry system• reusable glass cuvettes eliminate cost of disposable cuvettes• 4-parameter (Na+, K+, Cl-, CO2) dry electrodes reduce

costs and maintenance time, increase reliability of results

• benchtop chemistry with moderately complex drugs-of-abuse and therapeutic drug monitoring testing

• TouchPro software with smart icons guides operator through daily workflow, including configurable daily checklists

• 4-parameter (Na+, K+, Cl-, CO2) dry electrodes reduce costs and maintenance time, increase reliability of results

• open architecture: program any EIA or CLIA protocol, fully customizable with flexible, intuitive software

• space saving: high capacity (96 samples) in 2 ft. × 2 ft. footprint

• cost saving: low instrument price point with no routine consumables required


JUNE 2019 page 55





Part 4 of 6 Horiba Medical HYCOR Biomedical MedTest DxEd Salanga [email protected] Lorraine Damico [email protected] Tracy Luciano [email protected], CA Garden Grove, CA Canton, MI888-903-5001 www.horiba.com/us/en/medical/ 800-382-2527 www.hycorbiomedical.com 734-487-8300 www.medtest.com

Name of instrument Pentra C400 HYTEC 288 PLUS Spotchem Type of instrument chemistry immunoassay chemistry

Operational type/Model type batch, random access, continuous random access, discrete/benchtop

batch/benchtop discrete/benchtop

List price/First year sold in U.S. $100,000/2006 $55,000/1999 $13,000/2006Targeted hospital bed size/Targeted test volume ≤ 250/daily: 1,200; monthly: 24,000; annual: 288,000 200/variable —/daily: 250; monthly: 1,000; annual: 12,000Company manufactures instrument yes (also sold by Henry Schein, McKesson, Thermo Fisher,

Medline, LSI)yes (also sold by distribution partners) — (also sold by Core Lab Supplies)

Other models in this family of analyzers Pentra 400 — —No. of units in clinical use in U.S./Outside U.S. (countries) 650/ 1,900 > 100/ > 200 (Canada, Europe, Middle East, South America) > 100/ > 100

Dimensions (H × W × D)/Instrument footprint 25 × 40 × 28 in./7.7 sq. ft. 29.5 × 42.5 × 27.5 in./8 sq. ft. 6.5 × 13.5 × 8 in./—Weight empty/Weight fully loaded 264 lbs./266 lbs. 198 lbs./198 lbs. 12 lbs./—No. of different measured assays onboard simultaneously 55 (55 can be run and calibrated at one time) up to 288 (up to 288 can be run and calibrated at one time) 8 (up to 21 can be run and calibrated at one time)No. of user-definable (open chemistry) channels 40 (40 can be active simultaneously) 3 —Test throughput per hour/Assay run time 420 (4 tests in throughput)/1–10 min. (avg. 5 min.) 48 (288 tests in throughput)/6 hrs. 48

Chemistry:No. of direct ion-selective electrode channels 3 — 0Detection methods photometry, potentiometry, enzyme immunoassay — photometryStat time until completion/specimen throughput for:• Ion-selective electrode < 5 min./37 specimens per hr. — —• Basic metabolic panel 7.5 min./35 specimens per hr. — 9 min./48 specimens per hr.• Complete metabolic panel < 11 min./23 specimens per hr. — 9 min./48 specimens per hr.Typical time delay from ordering stat test until aspiration of sample < 1 min. — —

Immunoassay:Fully automated microplate immunoassay system — no —Methodologies supported — enzyme immunoassay —Separation methodologies — — —Stat time until completion of a ß-hCG test — — —• Typical time delay from test order to aspiration of sample — — —Stat time until completion of a cTn test — — —• Typical time delay from test order to aspiration of sample — — —

Approximate No. of tests per reagent set/Reagent type 100–400/self-contained multiuse, open reagent system 20 or 10/self-contained multiuse —/self-contained single useReagents refrigerated onboard/Reagents ready to use yes (2°–8°C)/variable; reagent specific no/yes no/yesReagent lot tracking/Reagent inventory yes/yes yes/no no/noReagent form/Reagents barcoded liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/no dry chemistry (closed reagent system)/yesSeparate reagent pack for each specimen/for each test run no/yes no/yes —/yesWalkaway capability/Walkaway duration yes/180 min. or 60 specimens or > 800 tests/assays yes/288 tests/assays yes/up to 15 min. or 1 specimen or up to 8 tests/assays

Design of sample-handling system rack rack trayUses washable cuvettes/Uses disposable cuvettes no/yes (can store up to 432 cuvettes) no/yes (can store up to 288 cuvettes) no/noMin.–max. sample volume that can be aspirated at one time 2–60 µL 50 µL maximum 5 µL minimumMin. reaction volume/Min. specimen volume/Min. dead volume 180 µL/2 µL/100 µL 10 µL/50 µL/100 µL 250 µL/—/—Dedicated pediatric sample cup yes (dead volume: 100 µL) no noPrimary tube sampling yes no noAccommodates most standard tube sizes/Accepts nonstandard tube sizes

yes/no yes/no —

Pierces caps on primary tubes no no noProtects against probe collision yes no noDetects clots/liquid level/short sample yes/yes/yes no/no/yes no/no/yesDetection or quantitation for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available hemolysis, icterus, lipemia, clots not available hemolysis, icterus, lipemia, clots not availableDilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to

analysis)/0yes (can be programmed to perform dilutions prior to analysis)/< 1 part per 10,000

no/—

Automatic rerun capability yes no noSample volume can be diluted to rerun out-of-linear-range high results yes no noSample volume can be concentrated to rerun out-of-linear-range low results

yes no no

Analyzer requires dedicated water supply no (average of 0.5 L/hr. consumption during operation) no noAutocalibration/Multipoint calibration supported yes (calibrants can be stored onboard)/yes (recommended

avg. frequency: 14 days)yes (calibrants are not stored onboard)/yes (recommended avg. frequency: monthly)

— (calibrants are not stored onboard)/no (recommended avg. frequency: per box)


2 hrs. (automatic)/—/—/avg. 14 days/— —/—/—/—/monthly —/—/—/per box/—

Automatic programmable start/Automatic programmable shutdown yes (5 min. start-up time)/no no/yes —/noOnboard real-time QC/Onboard software capability to review QC yes/yes yes/no no/noSupports multiple QC lot numbers per analyte no yes noWaste management direct to drain or container if no drain available manually by user manually by user

Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/yes yes (Codabar, Code 39)/— yes (Interleaved 2 of 5, Code 39, Code 128)/yesLab can control analyzer from remote computer no yes noInstrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) noSystem malfunctions can be diagnosed via remote monitoring yes no noUPS backup power supply no yes noData-management capability/LIS or EHR systems interfaced onboard/CGM LabDaq, Orchard, Cerner, Sunquest, Meditech,

Schuyler Houseonboard/— onboard/—

LIS interface provided/Bidirectional interface capability no/yes (broadcast download and host query) yes (additional cost)/yes (host query) no/—Modem servicing provided/Service engineer on-site response time no/< 24 hrs. no/within 48 hrs. yes/—

Mean time between failures avg. 250 days (displays error codes for troubleshooting) 210 days (displays error codes for troubleshooting) —Average scheduled maintenance time by lab personnel daily: < 5 min.; weekly: < 15 min.; monthly: < 30 min. daily: 10–15 min.; weekly: 20–25 min.; monthly: 20–25 min. —Maintenance records kept onboard for user/vendor yes (includes audit trail of who replaced parts)/no yes/no —/noMaintenance training demonstration module onboard no no noTraining included with purchase/Avg. time for basic user training yes (3 training slots)/2.5 days (at vendor or customer site) yes (2 training slots)/2 days (at customer site) —Advanced operator training/Extra charge for follow-up or advanced training

yes (at vendor site)/yes no/— no/—

Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (1 year)/— yes (1 year)†/—



• can run up to 55 assays onboard with 420 quality results per hour

• no requirement for an external water system; remote diagnostics available for real-time troubleshooting

• flexible, open-channel system with capability of having 40 third-party reagents onboard

• menu• ease of use• quality of results

• capable of storing up to 100 events of testing• test results available by built-in printer• 1 minute maintenance per day—only requirement is

to wipe down the reagent tray

†6 month warranty on field-tested (FT) Spotchem analyzers


JUNE 2019 page 56



Part 5 of 6 Nova Biomedical Roche Diagnostics Roche [email protected] Brittany Greiner [email protected] Brittany Greiner [email protected], MA Indianapolis, IN Indianapolis, IN800-458-5813 www.novabiomedical.com 800-428-5074 diagnostics.roche.com/us/en/home.html 800-428-5074 diagnostics.roche.com/us/en/home.html

Name of instrument Stat Profile Prime Plus cobas c 311 cobas e 411Type of instrument chemistry chemistry immunoassay

Operational type/Model type random access/benchtop random access, continuous random access/floor standing random access, continuous random access/benchtopList price/First year sold in U.S. —/2018 —/2009 —/2008Targeted hospital bed size/Targeted test volume — < 100/daily: < 200; monthly: < 40,000; annual: < 500,000 < 100/daily: < 200; monthly: < 40,000; annual: < 500,000Company manufactures instrument yes (also sold by distribution partners) no (manufactured by Hitachi High-Technologies) no (manufactured by Hitachi High-Technologies)Other models in this family of analyzers Stat Profile Prime CCS — —No. of units in clinical use in U.S./Outside U.S. (countries) — > 300/> 2,500 (> 50 countries) > 800/> 10,000 (> 50 countries)Dimensions (H × W × D)/Instrument footprint 18 × 14 × 16 in./1.5 sq. ft. 50 × 52 × 34 in./8.5 sq. ft. disk: 31.4 × 47.2 × 28.7 in./9.4 sq. ft.;

rack: 31.4 × 67 × 37.4 in./17.4 sq. ft. Weight empty/Weight fully loaded 35 lbs./42 lbs. 551 lbs./625 lbs. disk: 397 lbs./397 lbs.; rack: 551 lbs./551 lbs.No. of different measured assays onboard simultaneously 20 (20 can be run and calibrated at one time) 42 photometrics, 3 ISEs (up to 90 can be run and calibrated

at one time)18 (18 can be run and calibrated at one time)

No. of user-definable (open chemistry) channels 30 10 (10 can be active simultaneously) 0Test throughput per hour/Assay run time up to 38 (760 tests in throughput)/avg. 60 sec. up to 300 (300 tests in throughput)/3–10 min. (avg. 7 min.) 86 (86 tests in throughput)/9–27 min. (avg. 18 min.)

Chemistry:No. of direct ion-selective electrode channels 7 3 —Detection methods photometry, potentiometry, Severinghaus, amperometry,

conductivity, enzymephotometry, potentiometry —

Stat time until completion/specimen throughput for:• Ion-selective electrode 1 min./60 specimens per hr. 5 min./150 specimens per hr. —• Basic metabolic panel 1 min./60 specimens per hr. 8 min./60 specimens per hr. —• Complete metabolic panel 1 min./60 specimens per hr. 11 min./27 specimens per hr. —Typical time delay from ordering stat test until aspiration of sample 3 sec. < 1 min. —

Immunoassay:Fully automated microplate immunoassay system — — noMethodologies supported — — electrochemiluminescenceSeparation methodologies — — magnetic particleStat time until completion of a ß-hCG test — — ~10 min. • Typical time delay from test order to aspiration of sample — — < 1 min.Stat time until completion of a cTn test — — ~10 min.• Typical time delay from test order to aspiration of sample — — < 1 min.

Approximate No. of tests per reagent set/Reagent type 100, 200, 300, 400, or 500/self-contained multiuse 50–800/self-contained multiuse 100–200/self-contained multiuseReagents refrigerated onboard/Reagents ready to use no/yes yes (5°–15°C)/yes no (20° ±3°C)/yesReagent lot tracking/Reagent inventory yes/yes yes/yes yes/yesReagent form/Reagents barcoded liquid chemistry (closed reagent system)/yes liquid chemistry (open reagent system)/yes liquid chemistry (closed reagent system)/yesSeparate reagent pack for each specimen/for each test run no/no no/no no/noWalkaway capability/Walkaway duration yes/1 min. or 1 specimen or 20 tests/assays yes/60–180 min. or 108 specimens or 45 tests/assays yes/30–60 min. or 30 specimens (disk), 75 specimens (rack)

or 2,000–3,000 tests/assays

Design of sample-handling system probe ring disk: ring; rack: rackUses washable cuvettes/Uses disposable cuvettes no/yes yes/yes (can store up to 66 cuvettes) no/yes (can store up to 360 assay tips, 180 assay cups)Min.–max. sample volume that can be aspirated at one time 135 µL 1–35 µL 10–50 µLMin. reaction volume/Min. specimen volume/Min. dead volume 135 µL/135 µL/— 6 µL/51 µL/50 µL 100 µL/10 µL/100 µLDedicated pediatric sample cup no yes (dead volume: 50 µL) yes (dead volume: 50 µL)Primary tube sampling yes yes yesAccommodates most standard tube sizes/Accepts nonstandard tube sizes

yes/yes yes/yes (12 × 100 mm) yes/yes (12 × 100 mm)

Pierces caps on primary tubes no no noProtects against probe collision yes yes yesDetects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/yesDetection or quantitation for hemolysis, icterus, lipemia, clots detection for hemolysis, icterus, lipemia, clots detection for clots; quantitation for hemolysis, icterus, lipemia detection for clots; hemolysis, icterus, lipemia not availableDilutes patient samples onboard/Susceptibility to carryover no/— yes (can be programmed to perform sample dilutions prior to

analysis)/< 1 part per millionyes (can be programmed to perform sample dilutions prior to analysis)/0 (uses disposable tips)

Automatic rerun capability no yes yesSample volume can be diluted to rerun out-of-linear-range high results no yes yesSample volume can be concentrated to rerun out-of-linear-range low results

no yes yes

Analyzer requires dedicated water supply no yes (12 L/hr. consumption during operation) no (3 L consumption for 250 tests)Autocalibration/Multipoint calibration supported yes (calibrants can be stored onboard)/yes yes (calibrants are not stored onboard)/yes (recommended avg.

frequency: 24 hrs. [ISE]; once per lot [chemistry])yes (calibrants are not stored onboard)//yes (recommended avg. frequency: 28 days)


— 24 hrs./per lot/per lot/per lot/— —/—/—/—/28 days

Automatic programmable start/Automatic programmable shutdown yes (5 min. avg. start-up time)/yes no (5 min. start-up time)/yes yes (4 min. avg. start-up time)/yesOnboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yesSupports multiple QC lot numbers per analyte yes yes yesWaste management automated collection onboard instrument direct to drain automated collection onboard instrumentSample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, PDF417)/yesLab can control analyzer from remote computer yes yes noInstrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)System malfunctions can be diagnosed via remote monitoring yes yes yesUPS backup power supply no yes yesData-management capability/LIS or EHR systems interfaced onboard, optional add-on (NovaNet, more)/— onboard/SCC Soft Computer, Meditech, Cerner, Epic, Sunquest, more onboard/SCC Soft Computer, Meditech, Cerner, Epic, Sunquest, moreLIS interface provided/Bidirectional interface capability yes (included in instrument price)/yes (broadcast download

and host query)yes (included in instrument price)/yes (broadcast download and host query)

yes (included in instrument price)/yes (broadcast download and host query)

Modem servicing provided/Service engineer on-site response time no/within 8 hrs. yes/< 24 hrs. yes/< 24 hrs.

Mean time between failures — (displays error codes for troubleshooting) — (displays error codes for troubleshooting) — (displays error codes for troubleshooting)Average scheduled maintenance time by lab personnel weekly: 5 min.; monthly: 30 min. daily: 5 min.; weekly: 18 min.; monthly: 38 min. daily: 5 min.; weekly: 6 min.; monthly: 11 min.Maintenance records kept onboard for user/vendor yes (includes audit trail of who replaced parts)/yes (includes

audit trail of who replaced parts)yes (includes audit trail of who replaced parts)/yes (includes audit trail of who replaced parts)

some records/some records

Maintenance training demonstration module onboard yes yes yesTraining included with purchase/Avg. time for basic user training yes/30 min. (at customer site) yes (1 training slot)/1 week (at both vendor and customer sites) yes (1 training slot)/1 week (at both vendor and customer sites)Advanced operator training/Extra charge for follow-up or advanced training

yes/no yes (at vendor site)/yes yes (at vendor site)/yes

Warranty provided/Cost of annual service contract (24 h/7 d) yes (5 years)/— yes (1 year)/configuration dependent yes (1 year)/configuration dependent



• maintenance-free MicroSensor Card and disposable cartridge technology for sensors and reagents

• broad menu including iMg, BUN, creatinine, non-lysing CO-oximetry

• automated, liquid QC and supplemental quality monitoring for EP23A compliance and real-time verification of all analytical components during calibration, sample analysis, QC analysis

• drives lab efficiency with standardized instrumentation, reference ranges, consumables, and usage

• minimizes downtime with industry-leading service; 213-day mean time between repair visits (average)

• speeds up turnaround time for high-volume stat assays

• drives lab efficiency with standardized instrumentation, reference ranges, consumables, and usage

• minimizes downtime with industry-leading engineering and service; 325-day mean time between repair visits (average)

• speeds up turnaround time for high-volume stat assays


JUNE 2019 page 57

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.



Part 6 of 6 Tosoh BioscienceMimi Dang [email protected] San Francisco, CA800-248-6764 www.diagnostics.us.tosohbioscience.com

Name of instrument AIA-360Type of instrument immunoassay

Operational type/Model type continuous random access/benchtopList price/First year sold in U.S. —/2004Targeted hospital bed size/Targeted test volume —/monthly: < 500Company manufactures instrument no (manufactured by Tosoh Japan; also sold by McKesson,

Henry Schein, Fisher Healthcare, Medline, others)Other models in this family of analyzers AIA-900, AIA-2000No. of units in clinical use in U.S./Outside U.S. (countries) 2,000/6,500

Dimensions (H × W × D)/Instrument footprint 21 × 16 × 16 in./2.1 sq. ft.Weight empty/Weight fully loaded 61 lbs./—No. of different measured assays onboard simultaneously 25 (up to 4 can be run and calibrated at one time)No. of user-definable (open chemistry) channels —Test throughput per hour/Assay run time 36 (25 tests in throughput)/10 min.

Chemistry:No. of direct ion-selective electrode channels —Detection methods —Stat time until completion/specimen throughput for: —• Ion-selective electrode —• Basic metabolic panel —• Complete metabolic panel —Typical time delay from ordering stat test until aspiration of sample —

Immunoassay:Fully automated microplate immunoassay system —Methodologies supported fluorescenceSeparation methodologies —Stat time until completion of a ß-hCG test 20 min.• Typical time delay from test order to aspiration of sample —Stat time until completion of a cTn test 20 min.• Typical time delay from test order to aspiration of sample —

Approximate No. of tests per reagent set/Reagent type 100 (20 tests per tray)/unit dose test cupReagents refrigerated onboard/Reagents ready to use no/yesReagent lot tracking/Reagent inventory no/noReagent form/Reagents barcoded dry chemistry (closed reagent system)/yesSeparate reagent pack for each specimen/for each test run yes/—Walkaway capability/Walkaway duration yes/58 min. or 25 specimens or 25 tests/assays

Design of sample-handling system carouselUses washable cuvettes/Uses disposable cuvettes no/noMin.–max. sample volume that can be aspirated at one time 10– 500 µLMin. reaction volume/Min. specimen volume/Min. dead volume 150 µL/500 uL for test tube, 100 uL for cup/ 500 uL for test

tube, 100 uL for cupDedicated pediatric sample cup noPrimary tube sampling yesAccommodates most standard tube sizes/Accepts nonstandard tube sizes

yes/—

Pierces caps on primary tubes noProtects against probe collision —Detects clots/liquid level/short sample yes/yes/yesDetection or quantitation for hemolysis, icterus, lipemia, clots —Dilutes patient samples onboard/Susceptibility to carryover no/0Automatic rerun capability noSample volume can be diluted to rerun out-of-linear-range high results noSample volume can be concentrated to rerun out-of-linear-range low results

—

Analyzer requires dedicated water supply noAutocalibration/Multipoint calibration supported no (calibrants are not stored onboard)/yesTypical calibration frequency for ISE/therapeutic drugs/ drugs of abuse/general chemistries/immunoassays

—/—/—/—/90 days most assays

Automatic programmable start/Automatic programmable shutdown no (5 min. start-up time)/noOnboard real-time QC/Onboard software capability to review QC no/noSupports multiple QC lot numbers per analyte —Waste management automated collection onboard instrument

Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yesLab can control analyzer from remote computer noInstrument can diagnose its own malfunctions noSystem malfunctions can be diagnosed via remote monitoring —UPS backup power supply yesData-management capability/LIS or EHR systems interfaced Tosoh 501RP+/—LIS interface provided/Bidirectional interface capability no/noModem servicing provided/Service engineer on-site response time —

Mean time between failures > 6 months (displays error codes for troubleshooting)Average scheduled maintenance time by lab personnel daily: 5 min.Maintenance records kept onboard for user/vendor no/noMaintenance training demonstration module onboard noTraining included with purchase/Avg. time for basic user training yes/2 days (at customer site)Advanced operator training/Extra charge for follow-up or advanced training

—

Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/—



• immunoassay method free from biotin interference• compact size, broad menu with fast results• 90-day calibration stability for most assays



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